# K121622: Nidek RS-3000

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Mar 14, 2013 after 286 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K012727 (2002). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101505: Rtvue Model Rtvue 100, Optovue, Inc. (2010) Summary page 2.
- K111505: Rtvue Cam with Corneal Power Upgrade, Optovue, Inc. (2011) Summary page 2.
- K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000, Carl Zeiss Meditec, Inc. (2009) Summary page 2.

## Most influential descendants
- K132323: RS-3000 Advance (2014), 0 descendants of its own

## Indications for use
The Nidek Optical Coherence Tomography RS-3000 including scanning laser ophthalmoscope function with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of: * the retina, retinal nerve fiber layer, and optic disc, and * the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter), as an aid in the diagnosis and management of adults having or suspected of having ocular disease.

Source page: https://510kreport.com/device/K121622
Methodology: https://510kreport.com/methodology